Cleared Traditional

K884677 - MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM ...

K884677 is the FDA 510(k) clearance for MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM ... by Elscint, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K884677 · Elscint, Inc. · Radiology device
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Jan 1989
Decision
59d
Days
Class 2
Risk

K884677 is an FDA 510(k) clearance for the MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Elscint, Inc. (Itasca, US). The FDA issued a Cleared decision on January 6, 1989 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elscint, Inc. devices

Submission Details

510(k) Number K884677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date January 06, 1989
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K884677.
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
CYTOGUIDE
K885020 · Philips Medical Systems North America, Inc. · Apr 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · Elscint, Inc. · Jan 1989
BREAST LESION LOCALIZATION NEEDLE
K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · Fischer Imaging Corp. · May 1988